Caregiver BurdenNCT07250113
WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT
A study testing WeCareToFeedDysphagia web tool in people with Caregiver Burden and Alzheimer's Disease, run by Northwell Health at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a newly-created website tool, called WeCareToFeedDysphagia, helps to reduce feelings of burden in care partners of patients with Alzheimer's disease and related dementias (AD/ADRD) who were diagnosed with trouble swallowing (oropharyngeal dysphagia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden, Alzheimer's Disease, Dementia
- What is being tested?
- WeCareToFeedDysphagia web tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identifies as the primary care partner of an older adult patient (patient age ≥ 65 years) with AD/ADRD and oropharyngeal dysphagia (OD) admitted to the Northwell medicine service
- Age ≥ 18 years
- Designated as the legally authorized representative (LAR) or health care proxy (HCP), or designated by the LAR or HCP to participate
- Proficient in English
- Has access to a device (e.g. smartphone, iPad, computer) capable of accessing a web browser
Who cannot join
- Care partner of patient with a percutaneous feeding tube (i.e. PEG, PEJ used exclusively)
- Care partner of patient who will not be discharged to the home or community setting (e.g., home, assisted living, independent living)
- Care partner will not be involved with OD management (e.g. buying or making food, feeding, supervising) after hospital discharge
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Feinstein Institutes for Medical Research
Manhasset, New York, 11030
About this study
The goal of this clinical trial is to learn if a newly-created website tool, called WeCareToFeedDysphagia, helps to reduce feelings of burden in care partners of patients with Alzheimer's disease and related dementias (AD/ADRD) who were diagnosed with trouble swallowing (oropharyngeal dysphagia). The main questions this study aims to answer are:
- How effective is the WeCareToFeedDysphagia tool in reducing feelings of burden in care partners?
- Does the WeCareToFeed Dysphagia tool help improve patient outcomes?
- Does care partner age, gender, and patient dysphagia severity impact the strength of the effect of the WeCareToFeedDysphagia tool?
- Is the strength of the effect of the WeCareToFeedDysphagia tool impacted by care partner's beliefs in being able to manage behavior and stress (self-efficacy)?
Read more
Researchers will compare a group of care partners who have access to the WeCareToFeedDysphagia tool (intervention) to a group of care partners who do not have access to the tool. Both groups will receive contact information for help from a speech language pathologist expert (enhanced usual care).
Participants will:
- be given access to the web tool and receive 3 text message reminders over 3 weeks to use the tool (intervention group only).
- be asked to complete a remote, web-based survey three times: when enrolled in the study, at 1 month following patient leaving the hospital, and at 3 months following patient leaving the hospital.
- Being tested
- WeCareToFeedDysphagia web tool
- Medical subject headings
- Caregiver Burden, Alzheimer Disease, Dementia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeCareToFeedDysphagia web toolBehavioural
The web tool uses written and video content, care-partner testimonials, frequently asked questions, and resource links to provide accurate information (e.g., dysphagia diets), set realistic expectations, identify/support feeding goals (quality of life considerations), acknowledge/support care-partner feelings, and provide competencies/skills for oropharyngeal dysphagia (OD) management.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Control + WeCareToFeedDysphagia | Experimental | Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. Participants will also receive access to the WeCareToFeedDysphagia web tool and receive text message reminders to use the tool. Receives: Behavioral: WeCareToFeedDysphagia web tool |
| Enhanced Control | No intervention | Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Care Partner Burden at 3 Months Post Hospital Discharge
Burden will be measured using the Zarit Burden Scale (ZBI-22), a validated measure that assesses 22 statements related to personal strain accompanying caring for another person, which is rated with 5 frequency-related response categories, scored 0 (never) to 4 (nearly always). The total score ranges between 0 and 88 (higher scores indicating higher burden). A score greater than 21 has been suggested to indicate care-partner burden. Outcome measures will be captured through a link to an online questionnaire which will be sent to the care partner's smart phone/device via text message.
Measured: 3 months from hospital discharge
Secondary outcomes (4)
Mean Care Partner Burden at 1 Month Post Hospital Discharge
Burden will be measured using the Zarit Burden Scale (ZBI-22), a validated measure that assesses 22 statements related to personal strain accompanying caring for another person, which is rated with 5 frequency-related response categories, scored 0 (never) to 4 (nearly always). The total score ranges between 0 and 88 (higher scores indicating higher burden). A score greater than 21 has been suggested to indicate care-partner burden. Outcome measures will be captured through a link to an online questionnaire which will be sent to the care partner's smart phone/device via text message.
Measured: 1 month from hospital discharge
Mean Care Partner Quality of Life at 1 Month Post Hospital Discharge
Care Partner Quality of Life (CarerQol) will be measured using the validated Care-Related Qol-7D. The Care-Related Qol-7D measures well-being (CarerQol-VAS or visual analog scale) and subjective burden. The CarerQol-VAS measures happiness, using endpoints between 'completely unhappy' (0) and 'completely happy' (10). Subjective burden is measured on 7 dimensions (fulfillment, relational problems, mental health, daily activities problems, physical health, and support), and rated as (i) no, (ii) some, and (iii) a lot. The weighted score ranges from 0-100 (worst to best caregiving situation). Higher scores indicate higher quality of life. Outcome measures will be captured through a link to an online questionnaire which will be sent to the care partner's smart phone/device via text message.
Measured: 1 month from hospital discharge
Mean Care Partner Quality of Life at 3 Months Post Hospital Discharge
Care Partner Quality of Life (CarerQol) will be measured using the validated Care-Related Qol-7D. The Care-Related Qol-7D measures well-being (CarerQol-VAS or visual analog scale) and subjective burden. The CarerQol-VAS measures happiness, using endpoints between 'completely unhappy' (0) and 'completely happy' (10). Subjective burden is measured on 7 dimensions (fulfillment, relational problems, mental health, daily activities problems, physical health, and support), and rated as (i) no, (ii) some, and (iii) a lot. The weighted score ranges from 0-100 (worst to best caregiving situation). Higher scores indicate higher quality of life. Outcome measures will be captured through a link to an online questionnaire which will be sent to the care partner's smart phone/device via text message.
Measured: 3 months from hospital discharge
Percent Engagement with the WeCareToFeedDysphagia Tool
Engagement with WeCareToFeedDysphagia will be defined as percent of care partners viewing 2 or more pages within the tool. Success will be defined as greater than or equal to 45% of care partners engaging with the tool. Data will be captured via Google Analytics data to assess program usage in the domains of time/date of login, duration of page views, and document downloaded Engagement with the tool will be reported for the intervention arm only.
Measured: 3 months from hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start17 Feb 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 802 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Liron Sinvani, Northwell Health
- Investigators
- Liron Sinvani, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250113
- Sponsor's protocol ID
- 25-0388
- Other IDs
- R33AG079930
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data which can be sufficiently deidentified to preserve participant confidentiality will be made available via the Open Science Framework (OSF) repository. The goal of all shared data will be to facilitate replication of all primary and secondary, and exploratory study analyses as well as to allow for additional analyses with available data. Data will be redacted according to the safe-harbor method, and effective strategies will be adopted to minimize risk of disclosing a participant's identity. Data will be shared along with documentation of how variables were cleaned, coded, or summarized. In cases where participant-level data could be used to identify individuals, summary data will be presented (e.g. presenting an age category "\>85 years old" rather than individual participant age). Information about how summary data was generated will be provided in the data dictionary.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT
- ClinicalTrials.gov ID
- NCT07250113
- Acronym / sponsor ID
- 25-0388
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 802 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a newly-created website tool, called WeCareToFeedDysphagia, helps to reduce feelings of burden in care partners of patients with Alzheimer's disease and related dementias (AD/ADRD) who were diagnosed with trouble swallowing (oropharyngeal dysphagia). The main questions this study aims to answer are:
- How effective is the WeCareToFeedDysphagia tool in reducing feelings of burden in care partners?
- Does the WeCareToFeed Dysphagia tool help improve patient outcomes?
- Does care partner age, gender, and patient dysphagia severity impact the strength of the effect of the WeCareToFeedDysphagia tool?
- Is the strength of the effect of the WeCareToFeedDysphagia tool impacted by care partner's beliefs in being able to manage behavior and stress (self-efficacy)?
Researchers will compare a group of care partners who have access to the WeCareToFeedDysphagia tool (intervention) to a group of care partners who do not have access to the tool. Both groups will receive contact information for help from a speech language pathologist expert (enhanced usual care).
Participants will:
- be given access to the web tool and receive 3 text message reminders over 3 weeks to use the tool (intervention group only).
- be asked to complete a remote, web-based survey three times: when enrolled in the study, at 1 month following patient leaving the hospital, and at 3 months following patient leaving the hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Control + WeCareToFeedDysphagia | Experimental | Behavioral: WeCareToFeedDysphagia web toolParticipants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. Participants will also receive access to the WeCareToFeedDysphagia web tool and receive text message reminders to use the tool. |
| Enhanced Control | No intervention | –Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identifies as the primary care partner of an older adult patient (patient age ≥ 65 years) with AD/ADRD and oropharyngeal dysphagia (OD) admitted to the Northwell medicine service
- Age ≥ 18 years
- Designated as the legally authorized representative (LAR) or health care proxy (HCP), or designated by the LAR or HCP to participate
- Proficient in English
- Has access to a device (e.g. smartphone, iPad, computer) capable of accessing a web browser
Key exclusion criteria (3 listed)
- Care partner of patient with a percutaneous feeding tube (i.e. PEG, PEJ used exclusively)
- Care partner of patient who will not be discharged to the home or community setting (e.g., home, assisted living, independent living)
- Care partner will not be involved with OD management (e.g. buying or making food, feeding, supervising) after hospital discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeCareToFeedDysphagia web toolThe web tool uses written and video content, care-partner testimonials, frequently asked questions, and resource links to provide accurate information (e.g., dysphagia diets), set realistic expectations, identify/support feeding goals (quality of life considerations), acknowledge/support care-partner feelings, and provide competencies/skills for oropharyngeal dysphagia (OD) management. | Behavioural | Enhanced Control + WeCareToFeedDysphagia |
Primary outcome
Mean Care Partner Burden at 3 Months Post Hospital Discharge
Time frame: 3 months from hospital discharge
Burden will be measured using the Zarit Burden Scale (ZBI-22), a validated measure that assesses 22 statements related to personal strain accompanying caring for another person, which is rated with 5 frequency-related response categories, scored 0 (never) to 4 (nearly always). The total score ranges between 0 and 88 (higher scores indicating higher burden). A score greater than 21 has been suggested to indicate care-partner burden. Outcome measures will be captured through a link to an online questionnaire which will be sent to the care partner's smart phone/device via text message.
4 secondary outcomes
Mean Care Partner Burden at 1 Month Post Hospital Discharge
Time frame: 1 month from hospital discharge
Mean Care Partner Quality of Life at 1 Month Post Hospital Discharge
Time frame: 1 month from hospital discharge
Mean Care Partner Quality of Life at 3 Months Post Hospital Discharge
Time frame: 3 months from hospital discharge
Percent Engagement with the WeCareToFeedDysphagia Tool
Time frame: 3 months from hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. All data which can be sufficiently deidentified to preserve participant confidentiality will be made available via the Open Science Framework (OSF) repository. The goal of all shared data will be to facilitate replication of all primary and secondary, and exploratory study analyses as well as to allow for additional analyses with available data. Data will be redacted according to the safe-harbor method, and effective strategies will be adopted to minimize risk of disclosing a participant's identity. Data will be shared along with documentation of how variables were cleaned, coded, or summarized. In cases where participant-level data could be used to identify individuals, summary data will be presented (e.g. presenting an age category ">85 years old" rather than individual participant age). Information about how summary data was generated will be provided in the data dictionary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liron Sinvani, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeCareToFeedDysphagia web tool in people with Caregiver Burden and Alzheimer's Disease, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Care Partner Burden at 3 Months Post Hospital Discharge (time frame: 3 months from hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.